Companies announce phase 2 testing of heart failure treatment.
San Carlos, Calif.-based BioCardia, a provider of cardiovascular catheter systems, and Juventas Therapeutics said they will continue to work together to execute Juventas' phase 2 trial of JVS-100 for the treatment of heart failure.
The safety and efficacy study has been allowed by the FDA and enrollment is targeted to start in Q2 2012. The previous phase 1 trial enrolled 17 NYHA class 3 heart failure patients and showed promising safety and signals of clinical benefit to the patients treated.
"JVS-100 provides the potential for an off the shelf regenerative medicine therapeutic, with the potential to significantly enhance patients lives," said BioCardia CEO Peter Altman. "BioCardia's Helical catheter performed well in our phase 1 clinical trial and is an attractive delivery system for our targeted patient population," said Rahul Aras, Juventas CEO.
The Helical Infusion System is a CE Marked steerable two catheter system that enables delivery of biologic therapies to the heart muscle from within the chamber of the heart. It requires no external capital equipment and has an excellent clinical safety profile. The Helical Infusion System is commercially available in the European Union and is under Investigation in the United States in ongoing clinical trials.
JVS-100 encodes Stromal-cell Derived Factor 1 (SDF-1). SDF-1 promotes tissue repair through recruitment of endogenous stem cells to the damaged organ, promotion of new blood vessel formation and prevention of ongoing cell death. The SDF-1 repair pathway is well-conserved in a broad range of end organ systems, including the heart, vasculature, dermis, kidney, and eye. JVS-100 is currently being clinically evaluated for treatment of heart failure and late stage peripheral vascular disease and has been shown to protect and repair tissue following organ damage in a broad range of pre-clinical disease models.
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|Title Annotation:||In The Clinic ...|
|Publication:||Stem Cell Business News|
|Date:||Mar 26, 2012|
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